Hospitalization rates for children with respiratory syncytial virus (RSV) treated with palivizumab (Synagis) were lower in practice that they were in preliminary clinical trials, according to data from more than 7,000 cases reported to the Palivizumab Outcomes Registry.
Initial randomized studies found that 5.0% of infants treated with the drug had to be hospitalized for symptoms of RSV, but the hospitalization rate for treated patients in the registry was 1.5%. The registry data was reported on Saturday at the annual meeting of the American Academy of Pediatrics (AAP).
Often the opposite is true, said Mark Hudak, MD, chief of neonatology at the University of Florida in Jacksonville, who presented the findings. Drugs can work well in carefully controlled research studies but lose some of their efficacy once they move into everyday clinical settings, he said. Although registry data is not precisely comparable to data from randomized, placebo-controlled studies, “you can?t say the drug didn’t work as well in the real world as it did in the study,” Dr. Hudak said.
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